A Study to Test Whether Vicadrostat in Combination With Empagliflozin Helps People With Heart Failure
Boehringer Ingelheim · NCT06424288
Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.
Key facts
- Compensation
- Not posted. Ask the study team before screening.
- Who can join
- Ages 18+ · All sexes
- Healthy volunteers
- Not accepted (a condition is required)
- Study type
- Interventional · Phase 3
- Target enrollment
- 6712
- US sites recruiting
- 92
- Study start
- June 17, 2024
- Record last updated
- October 14, 2026
Status re-checked against ClinicalTrials.gov within the last 12 hours.
What the study is about
This study is open to adults aged 18 or above legal age with heart failure. People can join the study if they have heart failure symptoms and a left ventricular ejection fraction (LVEF) of 40% or more. The purpose of this study is to find out whether vicadrostat (BI 690517) in combination with empagliflozin helps people with heart failure.
Participants are put into 2 groups by chance. Every participant has an equal chance of being in each group. The groups are:
- Vicadrostat/empagliflozin group: participants take vicadrostat/empagliflozin as tablets once a day.
- Placebo/empagliflozin group: participants take placebo/empagliflozin as tablets once a day.
Participants can stay in the study as long as they benefit from treatment and can tolerate it. During this time, they visit their doctors regularly. The doctors regularly check participants' health and take note of any unwanted effects. The study staff may also contact the participants by phone. Participants also regularly answer questions about their well-being.
The study does not have a fixed duration. It continues until there is enough data to see if the treatment is working.
Being studied: vicadrostat; empagliflozin; placebo
Conditions: Heart Failure
Eligibility criteria
Copied from the official record. The study team makes the final decision at screening.
Show full criteria
Inclusion criteria
- At least 18 years old and at least of the legal age of consent in countries where it is greater than 18 years
- Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial
- Male or female participants. Women of childbearing potential (WOCBP) must be ready and able to use highly effective methods of birth control per International Conference on Harmonisation (ICH) M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly. A list of contraception methods meeting these criteria and instructions on the duration of their use is provided in the participant information
- Chronic Heart failure (HF) diagnosed at least 3 months before Visit 1, and in New York Heart Association (NYHA) class II-IV at Visit 1, with left ventricular ejection fraction (LVEF) ≥40% per local reading. A historical LVEF may be used if it was measured within 12 months prior to Visit 1, or the LVEF may be measured after study consent has been obtained and before randomisation at Visit 2
- Presence of structural heart abnormality (confirmed by any imaging modality; i.e. echocardiography at Visit 1, as defined by left ventricular hypertrophy or left atrial enlargement). Historical imaging may be used if performed within 12 months prior to Visit 1, or imaging may be completed after study consent has been obtained and before Visit 2
- Elevated N-terminal pro-brain natriuretic peptide (NT-proBNP) at Visit 1, analysed at the central laboratory at Visit 1:
- in participants with body mass index (BMI) \<27 kg/m²: ≥300 pg/mL for participants without atrial fibrillation (Afib) or atrial flutter (Aflutter) (at Visit 1 electrocardiogram (ECG)) and ≥900 pg/mL for participants with Afib or Aflutter (at Visit 1 ECG)
- in participants with BMI ≥27 kg/m² to \<35 kg/m²: ≥220 pg/mL for participants without Afib or Aflutter (at Visit 1 ECG) and ≥660 pg/mL for participants with Afib or Aflutter (at Visit 1 ECG)
- in participants with BMI ≥35 kg/m²: ≥125 pg/mL for participants without Afib or Aflutter (at Visit 1 ECG) and ≥375 pg/mL for participants with Afib or Aflutter (at Visit 1 ECG)
- At least one of the following:
- Currently treated with diuretic therapy e.g. loop diuretics or thiazides, and on a stable dose for at least 1 week prior to Visit 1
- Documented hospitalisation for HF within 6 months prior to Visit 1
- Elevated NT-proBNP at Visit 1, analysed at the central laboratory at Visit 1
- in participants without Afib or Aflutter (at Visit 1 ECG): ≥900 pg/mL
- for participants with Afib or Aflutter (at Visit 1 ECG): ≥1800 pg/mL
- Urine albumin-to-creatinine ratio (UACR) ≥30 mg/g, analysed at the central laboratory at Visit 1
- Treated according to best possible standard of care (SOC) (disregarding Sodium-dependent glucose co-transporter 2 inhibitors (SGLT2is) and Mineralocorticoid receptor antagonists (MRAs)) in accordance with applicable HF local/international guidelines and judgment of the investigator Further inclusion criteria apply.
Exclusion criteria
- Treatment with an mineralocorticoid receptor antagonist (MRA) (e.g. spironolactone, eplerenone, finerenone) within 14 days prior to Visit 1 or requiring such treatment before randomisation or planned during the trial based on the judgment of the investigator. Treatment with MRA should not be interrupted with the intention of enrolment into the study
- Treatment with amiloride, or other potassium-sparing diuretic within 14 days prior to Visit 1 or requiring such treatment before randomisation or planned during the trial based on the judgment of the investigator
- Receiving the following treatments:
- a direct renin inhibitor (e.g. aliskiren) at Visit 2
- more than one angiotensin-converting enzyme inhibitor (ACEI), angiotensin receptor blocker (ARB) or angiotensin receptor-neprilysin inhibitor (ARNI) used simultaneously at Visit 2
- In case of acute decompensated HF:
- i.v. inotrope, i.v. vasodilating drug (e.g. nitrate, nitroprusside), or i.v. natriuretic peptide (e.g. nesiritide, carperitide), or mechanical support (e.g. intra-aortic balloon pump, endotracheal intubation, mechanical ventilation, any ventricular assist device) within 24 hours prior to randomisation (Visit 2)
- i.v. diuretic with a dose that has been increased/intensified within 6 hours prior to randomisation (a stable dose of an i.v. diuretic is not exclusionary)
- Systemic mineralocorticoid replacement therapy (e.g. fludrocortisone) at Visit 2
- Other aldosterone synthase inhibitors, e.g. baxdrostat at Visit 2 or planned during the trial
- Myocardial infarction (MI), transient ischemic attack (TIA), stroke, coronary artery bypass graft (CABG) surgery, heart valve surgery/intervention or any other major surgery (major according to the investigator's assessment) within 90 days prior to Visit 2, or scheduled for major elective surgery (e.g. hip replacement, coronary artery bypass graft surgery/CABG)
- Percutaneous coronary intervention (PCI) ( scheduled or unscheduled) or any angiography using iodinated contrast agents in the 7 days prior to Visit 2
- Heart transplant recipient, awaiting heart transplant, or currently implanted left ventricular assist device (LVAD)
- Known cardiomyopathy based on infiltrative diseases (e.g. amyloidosis), accumulation diseases (e.g. haemochromatosis, Fabry disease), muscular dystrophies, hypertrophic obstructive cardiomyopathy or genetic hypertrophic cardiomyopathy,known pericardial constriction, or cardiomyopathy with potentially reversible cause such as stress or peripartum cardiomyopathy or cardiomyopathy induced by chemotherapy within the 12 months prior to Visit 1 and until Visit 2
- Acute inflammatory heart disease, such as acute myocarditis, within the 90 days preceding prior to Visit 1 and until Visit 2
- Known severe valvular heart disease (obstructive or regurgitant), as per investigator's judgment, or valvular heart disease scheduled for surgical or invasive procedures at Visit 1, or anticipated invasive treatment during the study Further exclusion criteria apply.
Recruiting US locations
Diagnostic and Medical Clinic
Mobile, AL 36604
Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com
Mobile Heart Specialists, PC
Mobile, AL 36608
Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com
Velocity Clinical Research-Chula Vista
Chula Vista, CA 91911
Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com
University of California Irvine
Orange, CA 92868
Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com
North America Research Institute
San Dimas, CA 91773
Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com
Amicis Research Center - Valencia
Santa Clarita, CA 91355
Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com
Orange County Research Center
Tustin, CA 92780
Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com
Bridgeport Hospital
Bridgeport, CT 06610
Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com
Flourish Research
Boca Raton, FL 33434
Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com
Bay Area Cardiology
Brandon, FL 33511
Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com
Clearwater Cardiovascular and Interventional Consultants
Clearwater, FL 33756
Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com
Cardiology Associates Research Co.
Daytona Beach, FL 32117
Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com
Malcom Randall VA Medical Center
Gainesville, FL 32608
Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com
Velocity Clinical Research-Hallandale Beach-67888
Hallandale, FL 33009
Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com
University of Florida Health Jacksonville
Jacksonville, FL 32209
Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com
East Coast Institute for Research, LLC - Jacksonville
Jacksonville, FL 32216
Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com
First Coast Cardiovascular Institute
Jacksonville, FL 32256
Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com
Clearwater Cardiovascular Consultants-Largo-69917
Largo, FL 33777
Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com
University of Miami
Miami, FL 33136
Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com
Sacred Heart Medical Specialty Group
Miramar Beach, FL 32550
Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com
Southwest Florida Research, LLC
Naples, FL 34102
Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com
Ocala Cardiovascular Research
Ocala, FL 34471
Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com
Ocala Research Institute, Inc
Ocala, FL 34471
Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com
Charlotte Cardiovascular Institute, PA
Port Charlotte, FL 33952
Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com
East Coast Institute for Research, LLC-Saint Augustine-63032
Saint Augustine, FL 32086
Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com
University of South Florida
Tampa, FL 33612
Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com
Cardiology Partners Clinical Research Institute
Wellington, FL 33449
Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com
Cozy Research LLC
Wesley Chapel, FL 33544
Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com
Flourish Research
Winter Park, FL 32789
Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com
Atlanta Clinical Research Centers
Atlanta, GA 30342
Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com
Columbus Regional Research Institute
Columbus, GA 31904
Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com
NSC Research Inc
Johns Creek, GA 30024
Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com
Kootenai Medical Center
Coeur d'Alene, ID 83814
Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com
Northwest Heart Clinical Research, LLC
Arlington Heights, IL 60005
Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com
Illinois Masonic Hospital
Chicago, IL 60657
Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com
Chicago Medical Research
Hazel Crest, IL 60429
Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com
Clinical Investigation Specialists, Inc.-Libertyville-69941
Libertyville, IL 60048
Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com
AMR Park Ridge
Park Ridge, IL 60068
Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com
Midwest Cardiovascular Research and Education Foundation
Elkhart, IN 46514
Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com
St. Francis Medical Group-Indiana Heart Physicians, Inc
Indianapolis, IN 46237
Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com
Indiana Medical Research Institute
Merrillville, IN 46410
Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com
Cardiovascular Research of Northwest Indiana, LLC
Munster, IN 46321
Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com
Reid Hospital
Richmond, IN 47374
Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com
The Iowa Clinic, PC
West Des Moines, IA 50266
Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com
West Houston Area Clinical Trial Consultants, LLC - Wichita
Wichita, KS 67226
Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com
Norton Heart Specialists
Louisville, KY 40205
Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com
Grace Research, LLC-Bossier City-51040
Bossier City, LA 71111
Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com
Heart Clinic of Hammond
Hammond, LA 70403
Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com
Grace Research, LLC-Shreveport-64616
Shreveport, LA 71105
Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com
Louisiana Heart Center - Slidell
Slidell, LA 70458
Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com
Ascension Saint Agnes Heart Care
Baltimore, MD 21229
Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com
AMR Dearborn
Dearborn, MI 48126
Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com
Sparrow Clinical Research Institute
Lansing, MI 48910-0826
Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com
Henry Ford Providence Hospital
Southfield, MI 48075
Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com
Trinity Health Michigan D/B/A Michigan Heart
Ypsilanti, MI 48197
Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com
Minneapolis VA Health Care System
Minneapolis, MN 55417
Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com
Jackson Heart Clinic, P.A.
Jackson, MS 39216
Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com
North Kansas City Hospital
North Kansas City, MO 64116
Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com
St. Louis Heart and Vascular, P.C.
St Louis, MO 63136
Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com
Velocity Clinical Research-Lincoln-69943
Lincoln, NE 68506
Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com
+ 32 more on the official record.
Study contacts (from the official record)
- Boehringer Ingelheim · 1-800-243-0127 · lintriage.rdg@boehringer-ingelheim.com
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